IP Library Granted Patent US 9,408,551
Granted Patent B2
US 9,408,551 · App. 15/066,883 · Granted Aug 9, 2016

System and method for facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer

Inventors: Gust H. Bardy (Carnation, WA); Ezra M. Dreisbach (Vashon, WA)
Assignee: BARDY DIAGNOSTICS, INC.
A61B5/0456A61B5/044A61B5/04017A61B5/0432A61B5/04085A61B5/6823
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Quick Facts
Patent No.
US 9,408,551
App. No.
15/066,883
Granted
Aug 9, 2016
Kind
B2
Abstract

R-R interval data is presented in a format that includes relevant near field and far field ECG data. The near field view provides a “pinpoint” classical view at classical recording speed. The far field view that provides an “intermediate” lower resolution, pre- and post-event view. Both ECG data views are temporally keyed to the extended duration R-R interval data that is scaled non-linearly to maximize the visual differentiation for frequently-occurring heart rate ranges. All three views are presented simultaneously. The durations of the pinpoint view, the intermediate view, and the R-R interval plot are flexible and adjustable. Diagnostically relevant cardiac events can be identified and located to allow pre- and post-event heart rhythm data. The pinpoint “snapshot” and intermediate views of ECG data with the extended term R-R interval data comparatively depicts heart rate context and patterns of behavior prior to and after a clinically meaningful arrhythmia or patient concern.

Claims (101)

1. A system for facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer, comprising:

an electrocardiogram (ECG) monitoring and recording device;

a download station adapted to retrieve cutaneous action potentials recorded for a set time period by the ECG monitoring and recording device as ECG data;

a processor and memory within which code for execution by the processor is stored, further comprising:

an identification module configured to identify a plurality of R-wave peaks in the ECG data;

a calculation module configured to calculate a difference between recording times of successive pairs of the R-wave peaks and to determine a heart rate associated with each time difference; and

a construction module configured to form an extended duration R-R interval plot over the set time period comprising each of the recording time differences and the associated heart rates; and

a display operatively coupled to the processor, for displaying:

the extended duration R-R interval plot with a temporal point of reference in the extended duration R-R interval plot; and

at least one accompanying ECG plot comprising at least part of the ECG data preceding and following the temporal point of reference as context.

2. A system in accordance with claim 1 , further comprising at least one of:

the at least one accompanying ECG plot adapted to be presented as a ECG view produced at a traditional paper-based ECG recording speed; and

the at least one accompanying ECG plot adapted to be presented as a lower resolution, pre- and post-event contextual view relative to the temporal point of reference.

3. A system in accordance with claim 1 , further comprising at least one of:

the construction module further configured to limit the heart rates to a range outside of which the time differences and the associated heart rates are excluded from the extended duration R-R interval plot; and

the construction module further configured to construct the extended duration R-R interval plot with a non-linear scale for the heart rates.

4. A system in accordance with claim 3 , wherein the non-linear scale for the heart rates is determined in accordance with the equation:

y

=

(

x

-

min

bpm

max

bpm

-

min

bpm

)

n

where x is the time difference, min bpm is the minimum heart rate (in beats per minute), max bpm is the maximum heart rate, and n<1.

5. A system in accordance with claim 1 , further comprising:

an ambulatory ECG monitor disposed for wear on the patient's chest along the sternum and adapted to record the cutaneous action potentials, the ambulatory ECG monitor adapted to be interfaced to a pair of cutaneous electrodes adhered to the patient's skin along the sternal midline.

6. A system in accordance with claim 1 , the processor further comprising:

an identification module configured to identify a potentially-actionable cardiac event within the ECG data, and to select the plurality of R-wave peaks from the ECG data prior to and after the potentially-actionable cardiac event.

7. A system in accordance with claim 1 , the processor further comprising:

a diagnostic module configured to form a diagnosis based on heart rate variability patterns in the extended duration R-R interval plot.

8. A system in accordance with claim 7 , further comprising:

the diagnostic module further configured to detect atrial fibrillation by identifying a Gaussian-type distribution of heart rate variability in the extended duration R-R interval plot.

9. A system in accordance with claim 7 , further comprising:

a cardiac rhythm therapy delivery device programmed to deliver a therapy in response to the diagnosis.

10. A system in accordance with claim 1 , wherein the processor is configured to form:

a background information plot with the extended duration R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature; and

background information layered to or keyed with the extended duration R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature.

11. A method for facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer, comprising the steps of:

monitoring and recording cutaneous action potentials of a patient;

retrieving the cutaneous action potentials as electrocardiogram (ECG) data for a set time period and identifying a plurality of R-wave peaks in the ECG data;

calculating a difference between recording times of successive pairs of the R-wave peaks and determining a heart rate associated with each time difference;

forming an extended duration R-R interval plot over the set time period comprising each of the recording time differences and the associated heart rates;

displaying the extended duration R-R interval plot and identifying a temporal point of reference in the extended duration R-R interval plot; and

displaying at least part of the ECG data preceding and following the temporal point of reference as context in at least one accompanying ECG plot.

12. A method in accordance with claim 11 , further comprising at least one of the steps of:

presenting the at least one accompanying ECG plot as a ECG view produced at a traditional paper-based ECG recording speed; and

presenting the at least one accompanying ECG plot as a lower resolution, pre- and post-event contextual view relative to the temporal point of reference.

13. A method in accordance with claim 11 , further comprising at least one of the steps of:

limiting the heart rates to a range outside of which the time differences and the associated heart rates are excluded from the extended duration R-R interval plot; and

constructing the extended duration R-R interval plot with a non-linear scale for the heart rates.

14. A method in accordance with claim 13 , wherein the non-linear scale for the heart rates is determined in accordance with the equation:

y

=

(

x

-

min

bpm

max

bpm

-

min

bpm

)

n

where x is the time difference, min bpm is the minimum heart rate (in beats per minute), max bpm is the maximum heart rate, and n<1.

15. A method in accordance with claim 11 , further comprising the step of:

recording the cutaneous action potentials through an ambulatory ECG monitor disposed for wear on the patient's chest along the sternum, the ambulatory ECG monitor adapted to be interfaced to a pair of cutaneous electrodes adhered to the patient's skin along the sternal midline.

16. A method in accordance with claim 11 , further comprising the steps of:

identifying a potentially-actionable cardiac event within the ECG data; and

selecting the plurality of R-wave peaks from the ECG data prior to and after the potentially-actionable cardiac event.

17. A method in accordance with claim 11 , further comprising the step of:

forming a diagnosis based on heart rate variability patterns identified in the extended duration R-R interval plot.

18. A method in accordance with claim 17 , further comprising the steps of:

detecting atrial fibrillation by identifying a Gaussian-type distribution of heart rate variability in the extended duration R-R interval plot.

19. A method in accordance with claim 18 , further comprising the step of:

programming a therapy in response to the diagnosis into a cardiac rhythm therapy delivery device.

20. A method in accordance with claim 11 , further comprising at least one of the steps of:

including a background information plot with the extended duration R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature; and

layering or keying background information with the extended duration R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature.

21. A non-transitory computer readable storage medium storing code for executing on a computer system to perform the method according to claim 11 .

Assignments (3)
RELEASE OF SECURITY INTEREST (SENT FOR RECORDAL OCTOBER 25, 2021) Recorded Dec 14, 2021
From: JPMORGAN CHASE BANK, N.A.
To: BREATHE TECHNOLOGIES, INC.; HILL-ROM SERVICES, INC.; ALLEN MEDICAL SYSTEMS, INC.; WELCH ALLYN, INC.; HILL-ROM, INC.; VOALTE, INC.; BARDY DIAGNOSTICS, INC.; HILL-ROM HOLDINGS, INC.
Reel/Frame 058516/0312 →
SECURITY AGREEMENT SUPPLEMENT Recorded Oct 25, 2021
From: BARDY DIAGNOSTICS, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 058567/0677 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 17, 2016
From: BARDY, GUST H.; DREISBACH, EZRA M.
To: BARDY DIAGNOSTICS, INC.
Reel/Frame 038014/0252 →
Continuity (6)
Continuation In Part 14997416 · Jan 15, 2016
Continuation In Part 14614265 · Feb 4, 2015
Continuation In Part 14488230 · Sep 16, 2014
Continuation In Part 14080725 · Nov 14, 2013
Provisional Application 62132497 · Mar 12, 2015
Related Publication 20160192853A1 · Jul 7, 2016